Trial Outcomes & Findings for Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension (NCT NCT01489670)

NCT ID: NCT01489670

Last Updated: 2014-03-28

Results Overview

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.

• Recruitment status: COMPLETED
• Target enrollment: 387 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2014-03-28

Participant Flow

Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. There was no investigational drug administered in this study.

Participant milestones

Measure	Lumigan® 0.01% Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Overall Study STARTED	387
Overall Study COMPLETED	334
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Measure	Lumigan® 0.01% n=387 Participants Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Age, Customized 18 to 30 Years	1 Participants n=93 Participants
Age, Customized 31 to 40 Years	3 Participants n=93 Participants
Age, Customized 41 to 50 Years	28 Participants n=93 Participants
Age, Customized 51 to 60 Years	53 Participants n=93 Participants
Age, Customized 61 to 70 Years	113 Participants n=93 Participants
Age, Customized 71 to 80 Years	120 Participants n=93 Participants
Age, Customized 81 to 90 Years	62 Participants n=93 Participants
Age, Customized >=91 Years	5 Participants n=93 Participants
Age, Customized Missing data	2 Participants n=93 Participants
Sex: Female, Male Female	237 Participants n=93 Participants
Sex: Female, Male Male	150 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All participants with complete data available for IOP.

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.

Outcome measures

Measure	Lumigan® 0.01% n=335 Participants Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Intraocular Pressure (IOP) at Baseline Right Eye (n=334)	22.0 mm Hg Interval 10.0 to 50.0
Intraocular Pressure (IOP) at Baseline Left Eye	22.0 mm Hg Interval 7.0 to 52.0

PRIMARY outcome

Timeframe: Week 12

Population: All participants with complete data available for IOP.

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.

Outcome measures

Measure	Lumigan® 0.01% n=335 Participants Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Intraocular Pressure (IOP) at Week 12 Right Eye (n=334)	16.0 mm Hg Interval 1.0 to 32.0
Intraocular Pressure (IOP) at Week 12 Left Eye	16.0 mm Hg Interval 8.0 to 28.0

SECONDARY outcome

Timeframe: Week 12

Population: All participants with data available for this outcome measure.

The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.

Outcome measures

Measure	Lumigan® 0.01% n=405 Eyes Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Physician Evaluation of Efficacy Using a 5-Point Scale IOP lower than target	87 Participants
Physician Evaluation of Efficacy Using a 5-Point Scale Target IOP reached	187 Participants
Physician Evaluation of Efficacy Using a 5-Point Scale IOP decreased but target not reached	64 Participants
Physician Evaluation of Efficacy Using a 5-Point Scale IOP increased	6 Participants
Physician Evaluation of Efficacy Using a 5-Point Scale No Change	15 Participants

SECONDARY outcome

Timeframe: Week 12

Population: All participants with data available for this outcome measure.

Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.

Outcome measures

Measure	Lumigan® 0.01% n=324 Participants Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale Very good	157 Participants
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale Good	144 Participants
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale Moderate	7 Participants
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale Poor	16 Participants

SECONDARY outcome

Timeframe: Week 12

Population: All participants with data available for this outcome measure.

The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.

Outcome measures

Measure	Lumigan® 0.01% n=333 Participants Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Physician Evaluation of Tolerability of Treatment Very good	174 Participants
Physician Evaluation of Tolerability of Treatment Good	141 Participants
Physician Evaluation of Tolerability of Treatment Moderate	12 Participants
Physician Evaluation of Tolerability of Treatment Poor	6 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: All participants who discontinued treatment early.

The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.

Outcome measures

Measure	Lumigan® 0.01% n=53 Participants Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Physician Reported Reasons for Early Discontinuation of Treatment Unacceptable ocular tolerability	28 Participants
Physician Reported Reasons for Early Discontinuation of Treatment Patient decision to withdraw from study	21 Participants
Physician Reported Reasons for Early Discontinuation of Treatment Insufficient IOP control	18 Participants
Physician Reported Reasons for Early Discontinuation of Treatment Physician decision to withdraw patient from study	8 Participants
Physician Reported Reasons for Early Discontinuation of Treatment Patient lost to follow up	1 Participants
Physician Reported Reasons for Early Discontinuation of Treatment Other reason	6 Participants
Physician Reported Reasons for Early Discontinuation of Treatment Missing data	1 Participants

SECONDARY outcome

Timeframe: Week 12

Population: All participants with data available for this outcome measure.

The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?

Outcome measures

Measure	Lumigan® 0.01% n=345 Participants Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Number of Patients Continuing Treatment After 12 Weeks	302 Participants

Adverse Events

Lumigan® 0.01%

Serious events: 0 serious events

Other events: 148 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lumigan® 0.01% n=387 participants at risk Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Eye disorders Conjunctival hyperaemia	19.4% 75/387
Eye disorders Eye irritation	11.9% 46/387
Eye disorders Eye pruritus	7.0% 27/387

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER